Evaluation of sFlt-1/PlGF Ratio ,OPG and sEng as Predictive Biomarkers in the Diagnosis and Treatment Evaluation of Preeclampsia

NCT07349277 | Recruiting DMC

• 1 other identifier: 35918
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

his study investigates the effectiveness of three specific biological markers (biomarkers) in the blood-the sFlt-1/PlGF ratio, soluble endoglin (sEng), and osteoprotegerin (OPG)-to better diagnose and monitor preeclampsia. Preeclampsia is a serious pregnancy complication characterized by high blood pressure and potential organ damage that affects 2-8% of pregnancies worldwide

Conditions

Preeclampsia; Gestational Hypertension; Hypertensive Disorders of Pregnancy

Keywords

sFlt-1/PlGF ratio; Soluble Endoglin (sEng); Osteoprotegerin (OPG); Angiogenesis; Placental Dysfunction; Preeclampsia; methyldopa

Outcome Measures

Primary Outcomes (5)

• Serum sFlt-1 concentration

  Measurement of serum sFlt-1 levels in maternal serum using ELISA

  At enrollment (20-36 weeks of gestation)

• Serum PlGF concentration

  Measurement of serum placental growth factor (PlGF) levels in maternal serum using ELISA.

  At enrollment (20-36 weeks of gestation)

• sFlt-1/PlGF ratio

  Calculated ratio of serum sFlt-1 to serum PlGF concentrations

  At enrollment (20-36 weeks of gestation)

• Serum Osteoprotegerin (OPG) concentration

  Measurement of serum osteoprotegerin (OPG) levels in maternal serum using ELISA.

  At enrollment (20-36 weeks of gestation)

• Serum sENG(Souble Endoglin) concentration

  Measurement of serum soluble endoglin (sENG) levels in maternal serum using ELISA.

  At enrollment (20-36 weeks of gestation)

Study Arms (3)

Preeclampsia - No Antihypertensive Treatment

This group includes pregnant women diagnosed with preeclampsia. Blood samples are collected at the time of diagnosis before starting any antihypertensive treatment. All participants will receive standard clinical care after sample collection. Samples will be processed, aliquoted, and stored at -80°C for biomarker analysis (sFlt-1, PlGF, soluble endoglin, and osteoprotegerin).

Preeclampsia - With Antihypertensive Treatment

is group includes pregnant women diagnosed with preeclampsia who are receiving standard antihypertensive therapy as part of their clinical care. Blood samples (5 mL) will be collected for measurement of biomarkers (sFlt-1, PlGF, sEng, OPG). Samples will be processed, aliquoted, and stored at -80°C. Clinical parameters and treatment details will also be recorded for analysi

Healthy Pregnant Controls

his group includes healthy pregnant women without preeclampsia. Blood samples (5 mL) will be collected to serve as controls for biomarker analysis. Samples will be processed, aliquoted, and stored at -80°C. Participants will receive routine prenatal care.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

he study population will include pregnant women aged 18-45 years, between 20 and 36 weeks of gestation, attending the antenatal clinic at the study site. Participants will be divided into three groups: Pregnant women diagnosed with preeclampsia who have not yet received antihypertensive treatment. Pregnant women diagnosed with preeclampsia who are receiving antihypertensive treatment. Healthy pregnant women serving as control subjects. Exclusion criteria include pre-existing chronic hypertension, renal disease, diabetes mellitus, multiple gestations, or autoimmune disorders. All participants will provide informed consent before enrollment. Blood samples will be collected for biomarker analysis (sFlt-1, PlGF, soluble endoglin, and osteoprotegerin). This population has been selected to allow comparison of biomarker levels in different clinical scenarios and to evaluate their

You may qualify if:

• Pregnant women between 20 and 36 weeks of gestation
• Age between 18 and 45 years
• Attending the antenatal clinic at the study site

You may not qualify if:

• Chronic hypertension
• Renal disease
• Diabetes mellitus
• Multiple gestations
• Autoimmune disorders

Sponsors & Collaborators

• Ammar Jassim Abed: lead

Study Sites (1)

Bint Al Huda Maternity Hospital

Nasiriyah, Dhi Qar, 64001, Iraq

RECRUITING

Related Publications (4)

• Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). The hypertensive disorders of pregnancy: ISSHP classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2018 Jul;13:291-310. doi: 10.1016/j.preghy.2018.05.004. Epub 2018 May 24. No abstract available.

  PMID: 29803330 BACKGROUND

• Miller JJ, Higgins V, Melamed N, Hladunewich M, Ma L, Yip PM, Fu L. Clinical Validation of the sFlt-1:PlGF Ratio as a Biomarker for Preeclampsia Diagnosis in a High-Risk Obstetrics Unit. J Appl Lab Med. 2023 May 4;8(3):457-468. doi: 10.1093/jalm/jfad003.

  PMID: 36869760 BACKGROUND

• Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

  PMID: 26735990 BACKGROUND

• Venkatesha S, Toporsian M, Lam C, Hanai J, Mammoto T, Kim YM, Bdolah Y, Lim KH, Yuan HT, Libermann TA, Stillman IE, Roberts D, D'Amore PA, Epstein FH, Sellke FW, Romero R, Sukhatme VP, Letarte M, Karumanchi SA. Soluble endoglin contributes to the pathogenesis of preeclampsia. Nat Med. 2006 Jun;12(6):642-9. doi: 10.1038/nm1429. Epub 2006 Jun 4.

  PMID: 16751767 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (5 mL each) will be collected from three groups of pregnant women: Women diagnosed with preeclampsia who are not receiving antihypertensive treatment. Women diagnosed with preeclampsia who are receiving antihypertensive treatment. Healthy pregnant women as control subjects. Serum will be separated by centrifugation and aliquoted into two tubes for storage. All samples will be frozen at -80°C for future biomarker analysis. Retained biospecimens will include serum samples only. Samples will be labeled with anonymized participant codes to protect privacy. They may be used for measurement of angiogenic and anti-angiogenic biomarkers (sFlt-1, PlGF, soluble endoglin, and osteoprotegerin)

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ammar Jassim Abed, MSc

CONTACT

+9647809561105; ammar.jassim11@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Student (MSc Researcher), Principal Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: October 10, 2025
• Primary Completion: January 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Supporting information to be shared includes the study protocol, statistical analysis plan (SAP), and analytic code. Data will be provided in an anonymized format, with requests reviewed by the principal investigator and shared under a data use agreement ensuring confidentiality. Data will be available 12 months after publication of the study results.

Locations

IR (1)